INVISIBLE PHYSICAL DEFENSE SPF 30- zinc oxide lotion

Invisible Physical Defense SPF 30 by

Drug Labeling and Warnings

Invisible Physical Defense SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide (20%)

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash occurs.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 30 minutes before sun exposure.
• Reapply at least every two hours.
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Butylene Glycol, Glycerin, Silica, Polyhydroxystearic Acid, PEG-10 Dimethicone, Argania Spinosa Kernel Oil, Cordyceps Sinensis Extract, Trametes Versicolor Extract, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Lavandula Spica (Lavender) Flower Oil, Tocopheryl Acetate, Sodium Chloride, Stearalkonium Hectorite, Pentylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Dimethicone Crosspolymer, Sodium Citrate, Propylene Carbonate, Xanthan Gum, Caprylyl Glycol, Bisabolol, Lavandula Hybrida Oil, Ethylhexylglycerin, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate.

Questions or comments

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

invisible
physical
defense

dermalogica

SPF
30

broad spectrum

weightless
physical
sunscreen

1.7 US FL OZ / 50 mL ℮

INGREDIENTS AND APPEARANCE

INVISIBLE PHYSICAL DEFENSE SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ARGAN OIL (UNII: 4V59G5UW9X)
OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
Sodium Chloride (UNII: 451W47IQ8X)
Stearalkonium Hectorite (UNII: OLX698AH5P)
Pentylene Glycol (UNII: 50C1307PZG)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Propanediol (UNII: 5965N8W85T)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Propylene Carbonate (UNII: 8D08K3S51E)
Xanthan Gum (UNII: TTV12P4NEE)
Caprylyl Glycol (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
Ethylhexylglycerin (UNII: 147D247K3P)
LAVANDIN OIL (UNII: 9RES347CKG)
Sodium Hydroxide (UNII: 55X04QC32I)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-909-01	1 in 1 CARTON	03/05/2020
1		7 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-909-02	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2020
3	NDC: 68479-909-04	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2020
4	NDC: 68479-909-00	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/05/2020

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-909)